If your email program has trouble displaying this email, view as a webpage. Recently Posted Guidance Documents 9/29/2021 - Benefit-Risk Assessment for New Drug and Biological Products 9/29/2021 - Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Guidance for Industry 9/29/2021 - Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Draft Guidance for Industry 9/29/2021 - Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for Industry 9/29/2021 - Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial: Draft Guidance for Industry 9/29/2021 - Electronic Submission Template for Medical Device 510(k) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff 9/28/2021 - Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment : Draft Guidance for Industry 9/28/2021 - Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry Guidance Document Search Search all FDA official guidance documents and other regulatory guidance

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